Medical Device Registration and Approval in Honduras

General country-specific regulatory information is provided on this page for medical device registration and approval in Honduras. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Honduras, free of charge, to expedite the preparation of your medical device or IVD registration application.

 

Medical Device Regulations and Classification in Honduras

REGULATORY AUTHORITY: Medical devices are regulated by the DGRS (Dirección General de Registros Sanitarios).

CLASSIFICATION SYSTEM: Devices are classified according to risk, following the EU model of Classes I, IIa, IIb, III, and IV.

TIMEFRAME: The licensing process takes approximately six months.

LICENSE VALIDITY: Licenses issued in Honduras expire after five years.

AUTHORIZED REPRESENTATIVE: An authorized representative is required.

ADDITIONAL INFORMATION: The licensing process is expedited for devices which have already been approved in Canada or Japan.

Last updated on January 29 2015.

Other Central America and the Caribbean Countries:

Belize, Costa Rica, Cuba, Dominican Republic, El Salvador, GuatemalaNicaragua, Panama

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